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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stopcock, i.v. set
510(k) Number K022895
Device Name ELCAM STOPCOCKS AND MANIFOLDS
Original Applicant
MEDICAL DEVICE CONSULTANTS, INC.
49 plain st.
north attleboro,  MA  02760 -4153
Original Contact daniel j dillon
Regulation Number880.5440
Classification Product Code
FMG  
Date Received09/03/2002
Decision Date 10/18/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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